As a dangerous drug attorney, I was disturbed to see a report linking a common ingredient in over-the-counter medicines to a potentially fatal condition. The U.S. Food and Drug Administration issued a safety warning April 7 about a link between benzocaine and a condition called methemoglobinemia. Patients with methemoglobinemia have reduced amounts of oxygen in their bloodstreams, causing the same symptoms they might have if they aren’t breathing at all — lightheadedness, blue or gray fingernails and lips, fatigue, rapid heart rate and shortness of breath. Benzocaine, which is found in gels and sprays for teething, canker sores and sore throats, has been linked to seven deaths and 319 bad reactions, mostly in babies and toddlers.
Methemoglobinemia is a rare condition, but it can cause death in extreme cases. Adults and children have developed the condition after using all strengths of benzocaine-containing products, after the first use or subsequent uses, and up to several hours after use. Most of those affected were children ages two and younger. The FDA’s statement advised parents not to use benzocaine in children under age two, except when supervised by a doctor. Adults are warned to follow the manufacturer’s advice when using the products and to keep them out of children’s reach. Adult patients who run an even greater risk include people who have breathing problems; heart disease; and certain genetic chemical deficiencies. Also at high risk are smokers and those who take drugs containing nitrates.
The FDA’s release notes that over-the-counter medicines containing benzocaine do not carry a warning about the risk of methemoglobinemia, and the agency says only that it will take more action if warranted. As a defective drug lawyer, I’m concerned about this lack of warnings, particularly for parents of young children. Teething children were identified as the group most vulnerable to methemoglobinemia, but an FDA press release does very little to get this information in front of their parents. Without a warning on the label, new parents — who are often too sleep-deprived to take care of their own health — may have no idea that there’s a risk of death from teething gels. The risk may be small, but it’s a risk that parents ought to have the tools to decide on for themselves. Current actions from the FDA and drug manufacturers just don’t provide those tools.
At Carey, Danis & Lowe, we represent clients who were seriously injured or sickened by a drug that was supposed to make them feel better. That includes over-the-counter drugs as well as prescription medications and all kinds of medical devices. Most of us trust that a drug wouldn’t be offered for sale if it weren’t safe to use, but unfortunately, multiple recalls over the last few years have shown the opposite. Our pharmaceutical liability attorneys represent people who were hurt or lost a loved one because of a drug that should never have been on the market. A lawsuit can’t erase a permanent health problem or bring back someone who was lost, but it can help families deal with the financial and emotional results, including high ongoing medical costs as well as loss of quality of life and other personal losses.
If your family has been hurt by a medication you thought you could trust, Carey, Danis & Lowe can help. To set up a free, confidential case evaluation, send us a message through our website or call us today at 1-877-678-3400.